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- Title
Impact of COVID‐19 on the Conduct and Design of Clinical Trials: IQ Consortium Perspective.
- Authors
Mohamed, Mohamed‐Eslam F.; Girish, Sandhya; Humeniuk, Rita; Nuthalapati, Silpa; Desai, Amit; Datta‐Mannan, Amita; Gheyas, Ferdous; Kanodia, Jitendra; Cheeti, Sravanthi; Zhu, Tong
- Abstract
This article discusses the impact of the COVID-19 pandemic on the design and conduct of clinical trials. A working group was formed to collect data on the experiences of IQ member companies regarding the pandemic's effects on clinical trials, including missed doses and missing pharmacokinetic/pharmacodynamic data. The survey results showed that the majority of clinical trials were conducted as planned, but some were paused or delayed. The pandemic also led to changes in trial design, such as reduced number of visits and wider sample collection windows. Mitigation strategies, such as remote visits and use of local laboratories, were implemented to minimize the impact of COVID-19 on trials. The article also includes case studies that highlight innovative approaches used during the pandemic, such as virtual matched healthy controls and decentralized trials. Overall, the findings provide valuable insights into the impact of the pandemic on clinical trials and offer potential strategies for future drug development.
- Subjects
EXPERIMENTAL design; CONSORTIA; COVID-19; COVID-19 pandemic; INTELLIGENCE levels
- Publication
Clinical Pharmacology & Therapeutics, 2024, Vol 116, Issue 1, p26
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1002/cpt.3242